Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,

Not Applicable

Completed

• Conditions: Blunt Expansion of the Uterine Incision
• Interventions: Procedure: Cephalad-caudad expansion; Procedure: Transversal expansion

• Registration Number: NCT01892215
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief Summary

Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted: 2013-06-30
• Study First Submitted QC: 2013-06-30
• Study First Posted: 2013-07-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 839

Inclusion Criteria

• Singleton pregnancies
• Gestational age: 34 weeks or more
• Delivery by cesarean section
• Presurgical hemoglobin > 10.5 g/dL

Exclusion Criteria

• Two or more previous cesarean sections
• History of uterine rupture in a previous pregnancy
• History of myomectomy
• History of abdominal trauma with an uterine lesion
• Blood dyscrasia
• Multiple pregnancy
• Placenta previa
• Abruptio placenta
• Stillbirth
• Sharp uterine expansion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cephalad-caudad	Cephalad-caudad expansion	Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
Transversal expansion	Transversal expansion	Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.

Primary Outcome Measures

Name	Time	Method
Blood loss (hemoglobin level)	72 hours	Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.

Secondary Outcome Measures

Name	Time	Method
Unintented extension of uterine incision	72 hours	Number of cases of unintended extension of the uterine incision during surgery between the two techniques.
Surgical complications	72 hours	Number of cases of surgical complications (hematomas, unintended extension of the uterine incision, need for transfusion) between the two techniques.
Hematoma formation	72 hours	Number of cases of hematoma formation during or after between the two techniques.
Need for transfusion	72 hours	Number of cases that required a blood transfusion between the two techniques.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama